search
Back to results

Mindfulness as a Method of Improving the Well-being, Quality of Life and Health of Primary School Pupils

Primary Purpose

Anxiety, Depression

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Mindfulness and compassion
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring mindfulness, children, anxiety, depression, mental disorder, risk factor

Eligibility Criteria

6 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • School pupils in grade 0-9

Exclusion Criteria:

  • No exclusion criteria

Sites / Locations

  • Center for Primary Health Care Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindfulness and compassion

Control group

Arm Description

Children aged between 6-16 years old will perform 5-10 minutes daily mindfulness and compassion training in school. The intervention will last for 10 weeks.

The control group consists of children who do not perform mindfulness in school.

Outcomes

Primary Outcome Measures

Effect of mindfulness on change in anxiety and depression in children, grade 3-9, as measured by the Beck Depression Inventory for Youth and the Beck Anxiety Inventory for Youth.
The primary aim is to evaluate if regular, daily, mindfulness and compassion practice (5-10 minutes) for 10 weeks prevents anxiety and depression in children, grade 3-9. Results will be compared within respective group (change from baseline) and between mindfulness and control group.

Secondary Outcome Measures

Effect of mindfulness on changes in daily life as measured by questions about school and leisure time (adapted from the Scania Public Health Survey).
To evaluate the effect of regular mindfulness on daily life in children, grade 0-9, as measured by a number of questions about school and leisure time (adapted from the Scania Public Health Survey).
Effect of regular mindfulness practice on school performance (data collected from school registers)
To evaluate the effect of regular mindfulness on grades and attendance. The report cards will be collected before the Swedish summer holidays commence in June
Effect of mindfulness on change in class room environment (evaluated by questionnaires, weekly schedule, and interviews with teachers).
To evaluate the effect of regular mindfulness on class room environment (evaluated by questionnaires, weekly schedule, and interviews with teachers).
Effect of risk factors on mental health: longitudinal follow-up study.
To evaluate the association between, and effect of, potential individual, family, and school-level factors on mental health in children and adolescents. First results are obtained at baseline via questionnaires, the next 10 weeks later. Thereafter yearly until ninth grade (questionnaires) and until 25 years of age (diagnoses via registers)
Effect of mindfulness on risk factors: longitudinal follow-up study.
The effect of mindfulness on potential individual, family, and school-level risk factors. First evaluation after 10 weeks. Thereafter yearly until ninth grade (questionnaires) and 25 years of age (diagnoses via registers).
Effect of mindfulness on changes in quality of life as measured by questions adapted from the Scania Public Health Survey and Living Conditions Surveys (ULF/SILC)
To evaluate the effect of regular mindfulness on quality of life in children, grade 0-9, as measured by questions adapted from the Scania Public Health Survey and Living Conditions Surveys (ULF/SILC)
Effect of mindfulness on changes in health as measured by questions about school and leisure time (adapted from the Scania Public Health Survey).
To evaluate the effect of regular mindfulness on health in children, grade 0-9, as measured by a number of questions about general health (adapted from the Scania Public Health Survey)
Long-term effect of mindfulness practice on anxiety, depression, daily life, quality of life and health as measured by the BDI Youth, the Scania Public Health Survey and Living Conditions Surveys (ULF/SILC) and registries: longitudinal follow-up study
Long-term follow-up of outcomes # 1, 2, 7 and 8 via questionnaires once a year until ninth grade, and health until 25 years of age (diagnoses via registers)

Full Information

First Posted
September 29, 2017
Last Updated
October 3, 2023
Sponsor
Lund University
Collaborators
Region Skane
search

1. Study Identification

Unique Protocol Identification Number
NCT03327714
Brief Title
Mindfulness as a Method of Improving the Well-being, Quality of Life and Health of Primary School Pupils
Official Title
Mindfulness as a Method of Improving the Well-being, Quality of Life and Health of Primary School Pupils in Grades 0-9 (Ages 6-16)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 12, 2016 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
June 30, 2039 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University
Collaborators
Region Skane

4. Oversight

5. Study Description

Brief Summary
This study evaluates the short and long-term effect of 5-10 minutes daily mindfulness and compassion training in school among children aged between 6-16 years old. The mindfulness intervention will last for 10 weeks and the results will be compared to children who do not perform mindfulness in school. Due to practical reasons, the study is not randomized; classes are instead placed in the mindfulness or control group. Anxiety, mental, physical and social health, quality of life, and school performance will be evaluated via questionnaires and school registries, before and after the intervention and thereafter once a year until the end of ninth grade (age 16 years). Long term health (diagnoses, medical consumption, and drug prescriptions) and family income (proxy for socioeconomic status) will be followed in regional and national registries until 25 years of age. The hypothesis of the study is that mindfulness can prevent mental disorders and anxiety, and increase well-being in children and adolescents. The primary aim is to subsequently evaluate if regular, daily, mindfulness and compassion training (5-10 minutes) prevents anxiety and mental disorders in children and adolescents. Secondary aims are to evaluate 1) the effect of mindfulness on daily life, quality of life, and health in school pupils; 2) the effect of mindfulness on school performance; 3) the effect of mindfulness and compassion on the class room environment; 4) the effect of potential individual, family, and school-level risk factors on mental health in children and adolescents; 5) the effect of mindfulness on these potential risk factors. Sessions are led by school teachers who have been educated in mindfulness. Their own levels of stress and mindfulness will be evaluated by a questionnaire and compared to teachers in control classes both before and after the intervention. The teachers will also be interviewed to evaluate the effect of mindfulness on the class room environment. In a sub-study, the effect of mindfulness on brain structure and function will be examined by magnetic resonance imaging in school pupils aged 15-16 year old. This will be preceded by a pilot study, in which feasibility of the method is tested in the target group. To achieve sufficient statistical power, taking into account a cluster effect to adjust for grouping of the pupils, 1750 children and adolescents will be recruited. Written informed consent is a prerequisite for participation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression
Keywords
mindfulness, children, anxiety, depression, mental disorder, risk factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Children in classes that perform regular mindfulness are compared to children in classes that do not.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness and compassion
Arm Type
Experimental
Arm Description
Children aged between 6-16 years old will perform 5-10 minutes daily mindfulness and compassion training in school. The intervention will last for 10 weeks.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group consists of children who do not perform mindfulness in school.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness and compassion
Primary Outcome Measure Information:
Title
Effect of mindfulness on change in anxiety and depression in children, grade 3-9, as measured by the Beck Depression Inventory for Youth and the Beck Anxiety Inventory for Youth.
Description
The primary aim is to evaluate if regular, daily, mindfulness and compassion practice (5-10 minutes) for 10 weeks prevents anxiety and depression in children, grade 3-9. Results will be compared within respective group (change from baseline) and between mindfulness and control group.
Time Frame
Change from baseline depression and anxiety levels at 10 weeks
Secondary Outcome Measure Information:
Title
Effect of mindfulness on changes in daily life as measured by questions about school and leisure time (adapted from the Scania Public Health Survey).
Description
To evaluate the effect of regular mindfulness on daily life in children, grade 0-9, as measured by a number of questions about school and leisure time (adapted from the Scania Public Health Survey).
Time Frame
Change from baseline daily life status at 10 weeks
Title
Effect of regular mindfulness practice on school performance (data collected from school registers)
Description
To evaluate the effect of regular mindfulness on grades and attendance. The report cards will be collected before the Swedish summer holidays commence in June
Time Frame
Grade 0 (pupils aged 6-7 years) and will continue on a yearly basis until grade 9 (pupils aged 15-16).
Title
Effect of mindfulness on change in class room environment (evaluated by questionnaires, weekly schedule, and interviews with teachers).
Description
To evaluate the effect of regular mindfulness on class room environment (evaluated by questionnaires, weekly schedule, and interviews with teachers).
Time Frame
Change from baseline class room environment at 10 weeks
Title
Effect of risk factors on mental health: longitudinal follow-up study.
Description
To evaluate the association between, and effect of, potential individual, family, and school-level factors on mental health in children and adolescents. First results are obtained at baseline via questionnaires, the next 10 weeks later. Thereafter yearly until ninth grade (questionnaires) and until 25 years of age (diagnoses via registers)
Time Frame
Baseline, 10 weeks, 52 weeks. Thereafter yearly until 25 years of age.
Title
Effect of mindfulness on risk factors: longitudinal follow-up study.
Description
The effect of mindfulness on potential individual, family, and school-level risk factors. First evaluation after 10 weeks. Thereafter yearly until ninth grade (questionnaires) and 25 years of age (diagnoses via registers).
Time Frame
10 weeks, 52 weeks. Thereafter yearly until 25 years of age.
Title
Effect of mindfulness on changes in quality of life as measured by questions adapted from the Scania Public Health Survey and Living Conditions Surveys (ULF/SILC)
Description
To evaluate the effect of regular mindfulness on quality of life in children, grade 0-9, as measured by questions adapted from the Scania Public Health Survey and Living Conditions Surveys (ULF/SILC)
Time Frame
Change from baseline quality of life at 10 weeks
Title
Effect of mindfulness on changes in health as measured by questions about school and leisure time (adapted from the Scania Public Health Survey).
Description
To evaluate the effect of regular mindfulness on health in children, grade 0-9, as measured by a number of questions about general health (adapted from the Scania Public Health Survey)
Time Frame
Change from baseline health at 10 weeks
Title
Long-term effect of mindfulness practice on anxiety, depression, daily life, quality of life and health as measured by the BDI Youth, the Scania Public Health Survey and Living Conditions Surveys (ULF/SILC) and registries: longitudinal follow-up study
Description
Long-term follow-up of outcomes # 1, 2, 7 and 8 via questionnaires once a year until ninth grade, and health until 25 years of age (diagnoses via registers)
Time Frame
52 weeks and thereafter yearly until 25 years of age.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: School pupils in grade 0-9 Exclusion Criteria: No exclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Sundquist, PhD, MD
Organizational Affiliation
Center for Primary Health Care Research, Institution of Clinical Sciences, Malmö, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Primary Health Care Research
City
Malmö
ZIP/Postal Code
20502
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Mindfulness as a Method of Improving the Well-being, Quality of Life and Health of Primary School Pupils

We'll reach out to this number within 24 hrs